PDA: Shaping the Global
Regulatory Landscape
PDA lives its motto – Connecting People, Science, and Regulation
®
– every day through
our engagement with health authorities and pharmacopeias around the world. In
harmony with our consensus-driven, peer-reviewed Technical Reports, PDA members
collaborate in Commenting Teams to develop responses to draft regulations and
guidances that refl ect our vision of maximizing product quality, availability, and value.
•
We advocate for global harmonization, simplifi cation, and effi ciency in the
regulations that impact the manufacturing science of pharmaceuticals,
biopharmaceuticals, and advanced therapies. Harmonization of regulatory
requirements—in both text and application—can drive innovation, quality
performance, and compliance.
•
We help guide regulators on emerging science and technology topics. As the industry
continues to shift from traditional pharmaceuticals and biologics to novel therapies,
and as manufacturing technology advances, PDA can identify and help health
authorities resolve real-world implementation questions before they impact patients.
PDA is uniquely positioned to help regulators create workable and innovative
regulatory solutions that protect product quality and availability. With more than
10,500 members and 26 chapters globally, PDA can gather diverse perspectives on
regulatory initiatives, and can connect regulators and experts on topics that impact
manufacturing science. PDA succeeds because of the hard work, determination, and
diversity of its volunteers and members.
As a PDA member, you are invited to participate in our commenting teams. To fi nd out how:
•
Explore our volunteer opportunities at pda.org/getinvolved
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Visit community.pda.org to join one of our Interest Groups
PDA's past regulatory comments are on our website at pda.org/regulatorycomments.
pda.org
